A class-action lawsuit accusing Boehringer Ingelheim and Sanofi of intentionally concealing risks in the popular heartburn medication Zantac has been filed in the U.S. District Court for the Northern District of California.
The suit maintains that Zantac has been found to contain a carcinogenic chemical at 26,000 times the limit approved by the U.S. Food & Drug Administration. The drug is manufactured by Paris-based Sanofi, whose North American headquarters are in Bridgewater, New Jersey; it previously was produced by German pharmaceutical firm Boehringer, whose North American headquarters are in Ridgefield.
Zantac contains the active ingredient ranitidine. When ingested, ranitidine metabolizes into N-nitrosodimethylamine (NDMA) which, the lawsuit states, the FDA, Environmental Protection Agency and World Health Organization classify as a carcinogen.
The FDA has established a permissible daily intake limit of 96ng of NDMA, but recent testing using FDA-approved methods detected more than 2,500,000ng of NDMA per 150mg tablet of Zantac. Each Zantac tablet has been found to contain 26,000 times the FDA-approved amount of NDMA that can be safely ingested daily.
The suit accuses Sanofi and Boehringer of violating state consumer-protection laws in its failure to disclose the harmful levels of NDMA in Zantac. It follows an FDA warning issued Friday that said it has detected a “probable” cancer-causing chemical in the medications, although it said patients can continue taking the medication for now. Both it and the European Commission are investigating Zantac and ranitidine for NDMA.
Zantac was the first drug to total $1 billion in sales. According to the lawsuit, “Zantac’s unprecedented sales were possible only because of a deception perpetrated by the drug’s manufacturers on consumers.”
Zantac maker Sanofi said in a statement it “takes patient safety seriously, and we are committed to working with the FDA.” Boehringer did not offer a comment.
“Millions of people in the U.S. suffer from heartburn, and for years, Zantac has been sold to the masses as a safe and easy-to-find remedy for that common ailment,” said Steve Berman, managing partner of Seattle-based Hagens Berman and attorney leading the case for consumers. “We’re certain that if those millions of consumers knew that the Zantac they take contains known carcinogens, they would be rightfully outraged.”
“Sanofi knew that Zantac contains a carcinogen, yet it chose to conceal these risks to the public to line its own pockets,” Berman said.
Attorneys say that despite the accumulating scientific evidence showing Zantac exposed users to extremely high levels of NDMA, neither Sanofi nor Boehringer disclosed that risk.
“Had defendants disclosed that Zantac results in unsafe levels of NDMA in the human body, no person, let alone a reasonable person, would have purchased and consumed Zantac,” the complaint states.
The lawsuit seeks to represent anyone who bought over-the-counter Zantac between Jan. 1, 2010 and the present. Attorneys hope to secure repayment for those who bought the drug, as well as a permanent injunction from the court under the Legal Remedies Act requiring the drug makers to either cease selling Zantac or add a warning to the label.
Last month, a report published by Coherent Market Insights said the global ranitidine market was valued at $412.4 million in 2017, and is projected to exhibit a compound annual growth rate of 1.8% over a forecast period of 2018-2026.
Boehringer Ingelheim bought the U.S. rights to Zantac from Pfizer for $509.5 million in cash in 2006. Sanofi acquired Zantac from Boehringer in 2016.